Parexel Blog

Parexel Blog

  • Virus Filtration: a key manufacturing step keeping medicines safe, including from emerging viruses like COVID-19

    Virus Filtration: a key manufacturing step keeping medicines safe, including from emerging viruses like COVID-19

    Virus retentive filters are filters used in biotechnology and plasma derived product drug substance manufacturing for the specific purpose of physically removing potential viruses from...

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  • Perspective on Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency

    Perspective on Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency

    In summary FDA is moving quickly to implement emergency use applications (EUAs) policy to provide flexibility to those manufacturers of face masks and respirators to meet the need of medical...

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  • New version 2 “The guidance on the management of clinical trials during COVID-19 (Coronavirus) pandemic” published on European Commission we

    New version 2 “The guidance on the management of clinical trials during COVID-19 (Coronavirus) pandemic” published on European Commission we

    After only one week since publishing of the first version on 20-Mar-2020, an updated version 2 of “The guidance on the management of clinical trials during COVID-19 (Coronavirus) pandemic” has...

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  • New global frameworks for managing clinical trials during COVID-19 emergency

    New global frameworks for managing clinical trials during COVID-19 emergency

    As global health authorities react and adjust to responding to the emerging COVID-19 threat to public health, one of the results has been more guidance, published much more often and without going...

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  • Where Do We Stand with COVID-19?

    Where Do We Stand with COVID-19?

      Since the first case of coronavirus (COVID-19) was identified in December 2019, cases have been confirmed on every continent but Antarctica, prompting the World Health Organization to declare...

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  • Back To The Future – Are You Prepared To Meet Unprecedented Demand to Use Old Drugs for New Purposes?

    Back To The Future – Are You Prepared To Meet Unprecedented Demand to Use Old Drugs for New Purposes?

    There has been significant momentum to begin repurposing existing drugs to find either prophylactic or acute treatments for COVID-19. These activities could result in further strains on...

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  • COVID-19 pandemic and regulatory guidelines on clinical trial conduct; similarities and differences between regions

    COVID-19 pandemic and regulatory guidelines on clinical trial conduct; similarities and differences between regions

    Introduction  Multiple global regulatory authorities have issued guidances and blogs to assist sponsors in managing and planning for the impact of the COVID-19 pandemic specifically on ongoing...

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  • FDA creates new temporary policy on the preparation of hand sanitizer products

    FDA creates new temporary policy on the preparation of hand sanitizer products

    In Summary The FDA is moving quickly to implement temporary Guidance to provide flexibility to those pharmacies and compounding centers to produce sanitizing solutions required to meet...

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  • COVID-19: Regulatory Impact

    COVID-19: Regulatory Impact

    The COVID-19 pandemic is suddenly and unexpectedly presenting us with a unique moment in history. In a time of global crisis and desperate human suffering, the world needs treatments and...

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  • FDA Takes Action to Accelerate Availability of COVID-19 Diagnostic Tests

    FDA Takes Action to Accelerate Availability of COVID-19 Diagnostic Tests

    In summary: In a direct and timely action to address the acute shortage of diagnostic tests currently available to test for COVID-19 disease, the FDA has issued a new policy that enables both...

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  • Desk-based Health Authority Inspections: A Risk-based Approach to Compliance

    Desk-based Health Authority Inspections: A Risk-based Approach to Compliance

    Increasingly over the last 10 years global regulators have looked to see how a greater reliance on desk-based inspection activities can support their surveillance programs.  This approach can be...

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  • Safer Technologies Program for Medical Devices (STeP): Initial Impressions

    Safer Technologies Program for Medical Devices (STeP): Initial Impressions

    On September 19, 2019, the FDA issued a draft guidance on the Safer Technologies Program for Medical Devices (STeP), which was created as a complement to the Breakthrough Devices Program. Similar...

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  • The Parexel Podcast | Episode 7: International Women’s Day - Insights from Ascending Davos

    The Parexel Podcast | Episode 7: International Women’s Day - Insights from Ascending Davos

    In this episode, Parexel Executive Vice President and Chief Commercial & Strategy Officer Peyton Howell interviews Meghan FitzGerald, Parexel Board Advisor and author of the new book Ascending...

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  • Understanding Department of Justice Enforcement Policies relating to FDA-Regulated Products

    Understanding Department of Justice Enforcement Policies relating to FDA-Regulated Products

    At the recent 2019 Enforcement, Litigation and Compliance Conference hosted by the Food and Drug Law Institute (see here), Deputy Assistant Attorney General David Morrell delivered the...

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  • The Parexel Podcast | Episode 6: The opportunity for biotechs in precision medicine

    The Parexel Podcast | Episode 6: The opportunity for biotechs in precision medicine

    Within the past 20 years, the field of precision medicine has been transformed. For biotech companies, this new landscape holds tremendous promise for innovation. So, why aren’t more...

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  • What Influences the Compliance Culture at FDA?

    What Influences the Compliance Culture at FDA?

    The Office of Compliance (OC) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) is a large organization.  It has hundreds of personnel who are...

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  • Regulatory Blog | Bioprocessing and Biologics risk from Coronavirus

    Regulatory Blog | Bioprocessing and Biologics risk from Coronavirus

    Coronavirus COVID-19 has been all over the news recently.  This virus is part of a larger family called Coronaviridae, which includes viruses that can infect only animals, cause mild colds...

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  • CAR-T: How far have we come and where are we going?

    CAR-T: How far have we come and where are we going?

    In this episode, Doug Olson, one of the first CAR-T patients treated on a clinical trial for CLL almost 10 years ago, details his experiences with this therapy in its earliest days....

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  • FDA & Nitrosamine Impurities – The Proverb of the King with Long Arms

    FDA & Nitrosamine Impurities – The Proverb of the King with Long Arms

    If the dictionary is to be believed, the expression that kings have long arms was first listed as a proverb in 1539 (see here).  Over time it has developed into the commonly recognized idea...

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  • Reflections on Cancer Drug Development Strategies with Newly-Introduced Chinese Regulations

    Reflections on Cancer Drug Development Strategies with Newly-Introduced Chinese Regulations

    The global cancer drug market is set to maintain strong growth over the next decade due to factors such as environmental pollution, population aging, and poor lifestyles that leave...

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